FDA.reportPublic FDA data

Ambler Surgical

Primary DI
00190660173500
Brand
Ambler Surgical
Company
AMBLER SURGICAL CORP.
Model
Outer sheath
Catalog number
96-205
Device description
Outer sheath, insulated, 10.0mm diameter, 210.0mm working length
Published
2021-01-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
FBMCannula and trocar, suprapubic, non-disposable

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FBMCannula And Trocar, Suprapubic, Non-DisposableGastroenterology, Urology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00190660173500PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00190660173500001906601735001906601735000190660173500

GMDN Terms#

Term, Definition table
TermDefinition
Rigid endoscopic tissue manipulation forceps, reusableA rigid, hand-held manual surgical instrument designed to be introduced through the working channel of an endoscope and/or an endoscopic port (e.g., laparoscopic port) primarily for grasping and manipulating tissues during endoscopic surgery. It has proximal controls (e.g., scissors-like handles), a rigid long slender shaft, and distal grasping jaws; it is not an electrosurgical device and is not dedicated to biopsy. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)407-0006sales@amblersurgical.com

Regulatory Flags#

DUNS number
015272206
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00190660029340Ambler SurgicalThornton triple vertical and 15 degree cutting edg21-328E2021-01-18
00190660000509Ambler SurgicalTendon approximator43-1602021-01-07
00190660002121Ambler SurgicalAir injection cannula1022E2021-01-07
00190660002138Ambler SurgicalAir injection cannula1328E2021-01-07
00190660002145Ambler SurgicalAir injection cannula1023E2021-01-07
00190660002152Ambler SurgicalAir injection cannula1031E2021-01-07
00190660002169Ambler SurgicalAir injection cannula1329E2021-01-07
00190660002176Ambler SurgicalAir injection cannula1026E2021-01-07
00190660002183Ambler SurgicalAir injection cannula1024E2021-01-07
00190660002190Ambler SurgicalAir injection cannula1028E2021-01-07
00190660002206Ambler SurgicalAir injection cannula1029E2021-01-07
00190660002213Ambler SurgicalAir injection cannula1027E2021-01-07
00190660002237Ambler SurgicalAir injection cannula1327E2021-01-07
00190660002244Ambler SurgicalAir injection cannula1030E2021-01-07
00190660002268Ambler SurgicalAir injection cannula1330E2021-01-07
00190660002329Ambler SurgicalAlio LASIK irrigation cannula5193E2021-01-07
00190660002343Ambler SurgicalAnis cortex aspirating cannula1429E2021-01-07
00190660002350Ambler SurgicalAnis cortex aspirating cannula1097E2021-01-07
00190660002824Ambler SurgicalBinkhorst irrigating cannula1332E2021-01-07
00190660002831Ambler SurgicalBinkhorst irrigating cannula1333E2021-01-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08403207004482Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004499Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004505Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004512Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004529Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004536Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
08403207004543Anmuth Medical InternationalAnmuth Medical International, LLCFBM2024-07-01
00842962130278HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130285HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130292HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130308HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962130315HNM MEDICALHNM STAINLESS, LLC.FBM2023-04-17
00842962109052HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109069HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109076HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109083HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109090HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109106HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109113HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-30
00842962109021HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842962109038HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842962109045HNM MEDICALHNM STAINLESS, LLC.FBM2023-03-29
00842331178023Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-14
00842331150944Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-12
00842331144011Novo Surgical Inc. NOVO SURGICAL, INC.FBM2022-11-11
00190660173449Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173456Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173463Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173470Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04
00190660173487Ambler SurgicalAMBLER SURGICAL CORP.FBM2021-01-04